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Enhanced Recovery Protocol for Pediatric Gastrointestinal Surgery (ENRICH-US Trial)
Phase 3
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pediatric patients ages 10-18
Undergoing elective (non-emergency) gastrointestinal/colorectal surgical procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours after surgery
Awards & highlights
ENRICH-US Trial Summary
This trial is designed to test the effectiveness of a new, 21-element protocol for children undergoing elective gastrointestinal surgery.
Who is the study for?
This trial is for children aged 10-18 with conditions like Crohn's Disease or Ulcerative Colitis, who are scheduled for elective gastrointestinal surgery. It's not open to those needing urgent surgeries or families unable to understand English or Spanish.Check my eligibility
What is being tested?
The ENRICH-US study tests a new perioperative care protocol designed to improve recovery after elective gastrointestinal surgery in kids. This multicenter trial compares traditional care with the new 21-element Enhanced Recovery Protocol.See study design
What are the potential side effects?
Since this trial focuses on surgical care procedures rather than medication, side effects may include typical post-surgical risks such as pain, infection at the incision site, and delayed recovery times.
ENRICH-US Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 18 years old.
Select...
I am scheduled for a planned surgery on my digestive system.
ENRICH-US Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of stay (LOS)
Secondary outcome measures
Hospital readmission
Immediate post-operative Quality of Life assessment
Intraoperative fluid use
+7 moreENRICH-US Trial Design
3Treatment groups
Active Control
Group I: ENRICH-US Implementation- midActive Control1 Intervention
Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator.
Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.
Group II: ENRICH-US Implementation- lateActive Control1 Intervention
Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator.
Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.
Group III: ENRICH-US Implementation- earlyActive Control1 Intervention
Baseline, pre-intervention data will be collected. This phase consists primarily of individual-level patient (ages 10-18 years undergoing elective GI surgery) data collection. This phase involves abstraction of existing electronic health records data by the Site Coordinator about current, standard perioperative care received by patients. Patients and parents will complete web-based HRQoL assessments preoperatively, and 5 days and 4-6 weeks post-operatively. Site-specific barriers and facilitators to implementation will be assessed by semi-structured, telephone interviews, conducted by each Site's PI and Coordinator.
Intervention phase will span 12 months with an implementation curriculum. Sites will be randomized to this implementation phase based on stepped-wedge cluster assignment. A sustainability phase will collect post intervention data.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,671,537 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
915,866 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is having an urgent surgery for a digestive system issue.I am between 10 and 18 years old.I am scheduled for a planned surgery on my digestive system.
Research Study Groups:
This trial has the following groups:- Group 1: ENRICH-US Implementation- mid
- Group 2: ENRICH-US Implementation- late
- Group 3: ENRICH-US Implementation- early
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which patients would be suitable for this clinical trial?
"This clinical study is open to any young person aged 10-18 that suffers from colitis or ulcerative. Most importantly, candidates should be able to meet the following prerequisites: be willing and able to have elective surgery, be pediatric patients ages 10-18."
Answered by AI
Is there any danger to patients from the ENRICH-US Implementation- mid?
"There is clinical evidence to support the efficacy of ENRICH-US Implementation- mid and it has received a score of 3 for safety."
Answered by AI
Are people over the age of 25 able to enroll in this clinical trial?
"The age requirement to take part in this study is between 10 and 18 years old."
Answered by AI
How many test subjects are being accepted into this experiment?
"Yes, the information available on clinicaltrials.gov suggests that this trial is still open and recruiting patients. The original posting was on July 1st, 2020 with the most recent update being on May 3rd, 2022. They are looking for a total of 1260 patients from a single location."
Answered by AI
Are patients presently being accepted into this trial?
"The most recent information on clinicaltrials.gov reveals that this clinical trial is currently seeking patients. This research was originally posted on July 1st, 2020 and was last updated on May 3rd, 2022."
Answered by AI
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